STERILITYDESCARTESNCT01331720
Assessment of the Effectiveness and Tolerability of Ovarian Hyperstimulation
An observational study of STERILITY, run by Ferring Pharmaceuticals at 14 sites in Spain.
Trial summary
The aim of the study is to assess the effectiveness of 5 mixed protocols of ovarian hyperstimulation with urinary gonadotrophins to achieve clinical pregnancy in females undergoing assisted reproductive techniques (IVF/ICSI) (in-vitro fertilisation/intracytoplasmic sperm injection). Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- STERILITY
- What is being tested?
- hMG-HP
- How many people
- 279 participants
- Where
- 14 sitesSpain
- Study dates
- Nov 2007to Jul 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Females affected by sterility able to undergo IVF/ICSI
Who may be able to join
- Body mass index (BMI) between 18 and 30
- Prolactin within the laboratory normal range
- Couples affected by sterility able to treat by IVF/ICSI (in-vitro fertilisation/intracytoplasmic sperm injection)
- Patients undergoing Menopur® and/or Bravelle® treatment
- Normal thyroid function
- Women not receiving clomifen citrate or gonadotrophins within one month prior study start
- Couples willing to participate in the study that have signed the informed consent form
Who cannot join
- Failure in 3 previous cycles of assisted reproduction IVF/ICSI (in-vitro fertilisation/intracytoplasmic sperm injection)
- Policystic ovarian syndrome
- Seminal samples not apt for IVF-ICSI (according to the criteria of each center)
- Evidence of significant bacterial infection in the seminogram of the couple in the preceding 6 months
- Antecedents of severe ovarian hyperstimulation syndrome (OHSS)
- Important systemic disease
- Pregnancy or contraindication to pregnancy
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Spain14 sites
Investigational site
Albacete, Albacete
Investigational site
Alicante, Alicante
Investigational site
Badajoz, Badajoz
Investigational site
Castellon, Castellón
Investigational site
Elche, Alicante
Investigational site
Gijón, Principality of Asturias
Investigational site
Málaga, Málaga
Investigational site
Mallorca, Mallorca
Investigational site
Murcia, Murcia
Investigational site
Navarra, Pamplona
Investigational site Sta. Cruz
Santa Cruz de Tenerife, Tenerife
Investigational site
Santiago de Compostela, La Coruña
Investigational site
Valencia, Valencia
Investigational site
Zaragoza, Zaragoza
About this study
Official title: Assessment of the Effectiveness and Tolerability of Ovarian Hyperstimulation Protocols Which Are the Most Common in Clinical Practice Using High Purified Gonadotrophins (u-FSH-HP y u-hMG-HP) in IVF/ICSI
The aim of the study is to assess the effectiveness of 5 mixed protocols of ovarian hyperstimulation with urinary gonadotrophins to achieve clinical pregnancy in females undergoing assisted reproductive techniques (IVF/ICSI) (in-vitro fertilisation/intracytoplasmic sperm injection).
Study hypothesis: mixed protocols with urinary FSH (follicle-stimulating hormone) and urinary hMG (human menopausal gonadotropin)should be more effective than monotherapy.
- Conditions
- STERILITY
- Being tested
- hMG-HP
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hMG-HPDrug
| Study group | Role | What they receive |
|---|---|---|
| FSH:LH 1:1 - Treatment Group A | Patients with a condition
LH (luteinizing hormone) Receives: Drug: hMG-HP | |
| FSH:LH 3:2 - Treatment Group B | Patients with a condition Receives: Drug: hMG-HP | |
| FSH:LH 3:1 - Treatment Group C | Patients with a condition Receives: Drug: hMG-HP | |
| FSH:LH 3:0 - Treatment Group D | Patients with a condition Receives: Drug: hMG-HP | |
| Initially FSH:LH 3:0 and on S6 FSH:LH 1:1 - Treatment Group E | Patients with a condition Receives: Drug: hMG-HP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
Measured: 0-30 days
Secondary outcomes (1)
Biochemical pregnancy rate
Measured: 0-16 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2011 (estimated)
- Study startNov 2007
- Primary completionMar 2009
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for STERILITYStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 279 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ferring SAU
- Investigators
- Clinical Development Support, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01331720
- Sponsor's protocol ID
- FER-MEN-2006-03
- Acronym
- DESCARTES
- Status last verified
- Apr 2011
- First submitted
- 6 Apr 2011
- Last updated
- 8 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effectiveness and Tolerability of Ovarian Hyperstimulation Protocols Which Are the Most Common in Clinical Practice Using High Purified Gonadotrophins (u-FSH-HP y u-hMG-HP) in IVF/ICSI
- ClinicalTrials.gov ID
- NCT01331720
- Acronym / sponsor ID
- DESCARTES / FER-MEN-2006-03
- Conditions
- STERILITY
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 279 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Ferring SAU
- Study start
- Nov 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 8 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to assess the effectiveness of 5 mixed protocols of ovarian hyperstimulation with urinary gonadotrophins to achieve clinical pregnancy in females undergoing assisted reproductive techniques (IVF/ICSI) (in-vitro fertilisation/intracytoplasmic sperm injection).
Study hypothesis: mixed protocols with urinary FSH (follicle-stimulating hormone) and urinary hMG (human menopausal gonadotropin)should be more effective than monotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| FSH:LH 1:1 - Treatment Group A | – | Drug: hMG-HPPatients with a condition LH (luteinizing hormone) |
| FSH:LH 3:2 - Treatment Group B | – | Drug: hMG-HPPatients with a condition |
| FSH:LH 3:1 - Treatment Group C | – | Drug: hMG-HPPatients with a condition |
| FSH:LH 3:0 - Treatment Group D | – | Drug: hMG-HPPatients with a condition |
| Initially FSH:LH 3:0 and on S6 FSH:LH 1:1 - Treatment Group E | – | Drug: hMG-HPPatients with a condition |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Females affected by sterility able to undergo IVF/ICSI
Key inclusion criteria (7 listed)
- Body mass index (BMI) between 18 and 30
- Prolactin within the laboratory normal range
- Couples affected by sterility able to treat by IVF/ICSI (in-vitro fertilisation/intracytoplasmic sperm injection)
- Patients undergoing Menopur® and/or Bravelle® treatment
- Normal thyroid function
Key exclusion criteria (7 listed)
- Failure in 3 previous cycles of assisted reproduction IVF/ICSI (in-vitro fertilisation/intracytoplasmic sperm injection)
- Policystic ovarian syndrome
- Seminal samples not apt for IVF-ICSI (according to the criteria of each center)
- Evidence of significant bacterial infection in the seminogram of the couple in the preceding 6 months
- Antecedents of severe ovarian hyperstimulation syndrome (OHSS)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hMG-HP | Drug | FSH:LH 1:1 - Treatment Group A, FSH:LH 3:0 - Treatment Group D, FSH:LH 3:1 - Treatment Group C, FSH:LH 3:2 - Treatment Group B, Initially FSH:LH 3:0 and on S6 FSH:LH 1:1 - Treatment Group E |
Primary outcome
Clinical pregnancy rate
Time frame: 0-30 days
1 secondary outcome
Biochemical pregnancy rate
Time frame: 0-16 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2011.
Related trials for STERILITY
RecruitingObservational study
International Pilot Study for Dual Non-invasive Assesment of Embryo Development
Infertility
Active, not recruitingObservational study
Retrieval of Sperm From Men With Azoospermia Using Ultrasound-guided Rete Testis Aspiration
Azoospermia, Nonobstructive, Infertility, Male
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
RecruitingObservational study
Impact of Infertility on the Sexual Sphere in Couples Undergoing Assisted Reproduction
Sexual Health Quality of Life, Infertile Patients
RecruitingObservational study
Pilot Study of Discarded Blastocysts
Infertility (IVF Patients)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Development Support study director
Ferring Pharmaceuticals
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of STERILITY, run by Ferring Pharmaceuticals at 14 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical pregnancy rate (time frame: 0-30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2011; AzTrials last refreshed its copy on 8 Nov 2026.